MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AHTB ACTIVE HEEL TRACTION BOOT; APPARATUS, TRACTION, NON-POWERED

Model Number	72202682
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery, while tightening the orange straps on the active heel traction boot the bolt/ washer that holds these straps in place snapped and broke away from the boot.It is unknown if there was a delay or how was the procedure completed.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, which was not used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records could not be performed because the serial number was not provided.Factors that are known to contribute to the alleged fault/failure may be a component failure or excessive force.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
Event or Problem Description
It was reported that during a hip arthroscopy, while tightening the orange straps on the active heel traction boot, the bolt/washer that holds these straps in place snapped and broke away from the boot.There was a delay of under 30 min and the procedure was completed using a s+n backup device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: AHTB ACTIVE HEEL TRACTION BOOT
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10425684
• Report Number: 3003604053-2020-00081
• Device Sequence Number: 14193876
• Product Code: HST
• UDI-Device Identifier: 00885554024807
• UDI-Public: 00885554024807
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202682
• Device Catalogue Number: 72202682
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 09/16/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 08/27/2020; 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1